The pharmaceutical industry, hospitals, care centers, laboratories and similar industries and facilities are constantly struggling against contaminations such as bacterial infections and viral infections which can spread. Hygiene issues are constantly on the topic and continuously evaluated. One hygiene issue of special character is the cleaning and sterilization of objects, such as reusable goods, disposable goods or other. For example, a pharmaceutical production site may be equipped with steam generators, water pretreatment apparatuses, closure processing systems, discharge systems, component washers, glassware washers, component sterilizers, terminal sterilization systems, isolators and sterility testing equipment, simply to clean and sterilize different reusable medical goods.
Reusable goods can be surgical equipment such as knifes, graspers, clamps, retractors, dialators, probes, scopes, drills, and saws, laboratory equipment such as bottles, bowls, condensers, funnels, flasks, pipettes, plates, media, cage fillings or the like. Any object which Is intended to be reused and which can be contaminated with hazardous or biological substances are the subject of harsh hygiene conditions. Whenever reusable goods has been used, such as reusable medical equipment, the reusable goods is sent for cleaning or sterilization.
The process of washing, disinfecting, drying and sterilizing reusable goods and/or disposable goods, such as reusable medical goods mentioned above, is a very high demanding process in terms of the facilities used, the staff, the process parameters, the apparatuses and even the ambient environment surrounding the apparatuses. All restrictions and conditions serving the purpose to reduce, or eliminate, the risk for contamination makes it difficult and costly to operate cleaning and sterilization processes.
Sterilization relates to a process that eliminates microbial life, including transmissible agents (such as fungi, bacteria, viruses, spore forms, etc.) present e.g. on or in a surface, contained in a fluid or powder, in medication, and/or on and/or in a compound such as biological culture media. Sterilization can be achieved by applying heat, chemicals, irradiation, high pressure, and filtration or combinations thereof.
Steam sterilization, or autoclaving, involves subjecting goods to steam at a high temperature. Steam sterilization involves the use of saturated steam under pressure and is a non-toxic method for sterilization. Further, steam sterilizers (autoclaves) are available in different sizes for different purposes. Four factors are relevant for the outcome of steam sterilization: steam, pressure, temperature and time. The sterilization time required varies depending on the goods to be sterilized. Chemical and biological indicators may be available for monitoring the sterilization process and to ensure that sterility is achieved. Properly executed steam sterilization will inactivate all fungi, bacteria, viruses and bacterial spores. If not all fungi, bacteria, viruses and bacterial spores can be removed or inactivated, the temperature, time and pressure is selected so that the sterilization device, and the method, has a Sterility assurance level, SAL, typically of at most 1/1.000.000, preferably lower than 1/1.000.000. SAL is used to describe the probability of a non-sterile unit exiting the device or method after the sterilization process has been completed.
Another example is high level disinfection (HLD), which is an accepted standard for the reprocessing of semi-critical devices, including flexible endoscopes, or for sterilization of critical or semi-critical devices that are heat-sensitive or incompatible with traditional sterilization methods. Endoscope reprocessing, for instance, involves the cleaning and disinfection of endoscopes, and may encompass the steps of cleaning, rinsing, disinfection, secondary rinsing, drying and storing. For drying, a drying cabinet is commonly utilized, which drying cabinet may comprise a door, a cabinet, a control circuit and a loading system such as one or several shelves or hooks. Use of the drying cabinet enables for immediate reuse of e.g. endoscopes, even after extended storage periods thereof.
During an on-going washing, disinfecting, drying and/or sterilizing process, an operator of the apparatus in which the process takes place, may be confronted with a need to prematurely stop the on-going process. A reason for intervening in the on-going process may for instance relate to an incorrect washing, disinfecting, drying and/or sterilizing program having been selected, a need to retrieve a loaded e.g. object or to add an object to the load, or having to adjust the placement of a load such as a bowl being turned upside-down. Unless the operator chooses to wait until the on-going process has been completed, which e.g. may take more than an hour, the operator commonly needs to activate an alarm in order to stop the on-going process. Activating an alarm may however be very stressful to the operator, who accordingly may feel disinclined to do so. Furthermore, choosing to stop the on-going process, e.g. by selecting a “Stop” button on a process screen associated with the apparatus and on-going process, may by the operator be perceived as a drastic measure, in that the act may be irrevocable. Additionally, the operator may not be knowledgeable of the impact on the load, should a door to the chamber containing the load be opened subsequent stopping the on-going process. The effect of the above is that the operator commonly chooses to avoid intervening in the on-going process, even though intervening in many cases would have been preferred.